[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Instituto Brasileiro de Controle do Cancer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100490422","efficacy-and-safety-of-ultrahypofractionated-radiotherapy-in-women-with-breast-cancer-receiving-regional-nodal-radiation-vs-nodal-moderate-hypofractionated-radiotherapy-100490422",false,"NCT05665920","Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy","Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy","HYPHEN","Inclusion Criteria:\n\n* Information to the patient and signed informed consent;\n* Women aged ≥18 years;\n* Breast conserving surgery;\n* Invasive adenocarcinoma (except classic invasive lobular carcinoma);\n* TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;\n* Eastern Cooperative Oncology Group (ECOG) 0 -1;\n* Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);\n* No previous breast or mediastinal radiotherapy;\n* No hematogenous metastases;\n* Ability to carry out long-term follow-up;\n\nExclusion Criteria:\n\n* Previous local irradiation;\n* Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;\n* Histology of metaplastic carcinoma;\n* History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.\n* Diagnosis of autoimmune and connective tissue diseases;\n* Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);\n* Indication of internal breast irradiation.","FEMALE","18 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy \u002F 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.",[27],"Malignant Breast Neoplasm",[29,30,31,32,33,34,35],"Dose splitting","Acute and late toxicity","Locoregional drainage irradiation","Breast neoplasm","Overall survival","Disease-free survival","Locoregional control","RECRUITING","2022-12-26",{"date":39,"type":40},"2022-12-29","ACTUAL",{"date":42,"type":40},"2022-10-18",{"date":44,"type":21},"2030-12-31",{"name":46,"class":47},"Instituto Brasileiro de Controle do Cancer","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100413921","accelerated-partial-breast-irradiation-versus-standard-or-hypofractionated-whole-breast-irradiation-in-early-breast-cancer-after-breast-conserving-surgery-100413921","NCT04669873","Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery","Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery","LAPIDARY","Inclusion Criteria:\n\n* Information to the patient and signed informed consent;\n* Women aged ≥50 years\n* Breast conserving surgery\n* Pathologic tumor size \\\u003C 3 cm (maximum microscopic diameter of the invasive component)\n* Invasive adenocarcinoma (except classic invasive lobular carcinoma)\n* Unifocal disease\n* Histopathologic grades I or II\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n* Lymphovascular invasion absent\n* Negative axillary lymph nodes\n* Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)\n* No prior breast or mediastinal radiotherapy\n* No hematogenous metastases\n\nExclusion Criteria:\n\n* Previous malignancy (except non-melanomatous skin cancer)\n* Mastectomy\n* Classical-Type Invasive Lobular Carcinoma\n* Neoadjuvant chemotherapy\n* Human Epidermal growth factor Receptor-type 2 positive (HER2+)\n* Triple-negative breast cancers\n* Intravascular lymphoma present\n* Contraindications to radiotherapy.\n* No geographical, social or psychologic reasons that would prevent study follow","50 Years","90 Years",{"count":20,"type":21},[24],"Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.\n\nThere are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.",[63],"Malignant Neoplasm of Breast",[65,66,67,68],"Breast Cancer","Radiotherapy","Hypofractionated","Breast-conserving surgery","2021-03-04",{"date":71,"type":40},"2021-03-08",{"date":69,"type":40},{"date":74,"type":21},"2026-12-31",{"name":46,"class":47},""]